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Evaluating Chemotherapy with INCB161734 for KRAS G12D-Mutated Pancreatic Cancer

This study is looking at how well standard chemotherapy works, both with and without an additional drug called INCB161734, for people with metastatic pancreatic ductal adenocarcinoma (PDAC). Metastatic means the cancer has spread. To join, you must have PDAC with a specific change in your cancer cells called a KRAS G12D mutation, and you cannot have received prior treatment for your metastatic cancer. The study aims to see if adding INCB161734 improves how long people live (Overall Survival) and how long they live without the cancer getting worse (Progression-free survival). The study plans to enroll 588 participants, but its current recruitment status is unclear.

Study design
This is an interventional study comparing chemotherapy with or without INCB161734. It plans to enroll 588 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your overall survival will be measured for up to approximately 3 years. Progression-free survival and objective response will be measured for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07522073

A Study to Evaluate Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma

Recruiting
PHASE3Ages 18+InterventionalTreatment
Incyte Corporation
~588 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:INCB161734PlaceboInvestigator's choice of chemotherapy

At a glance

Recruiting sites
36 of 219 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over Up to approximately 3 years
+2 more outcomes measured

Conditions

Solid Tumors

Explore related trials

Pancreatic Ductal AdenocarcinomaGTPase KRas

Where it's being run

219 sites across 54 states
Germany19
Spain17
France16
Italy12
California10
Belgium9
Japan9
United Kingdom9

Study leadership

  • Incyte Medical Monitor · STUDY_DIRECTOR · Incyte Corporation

Who to contact

Incyte Corporation Call Center (US)
[email protected]
1.855.463.3463
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically or cytologically confirmed metastatic PDAC with a KRAS G12D mutation
No prior systemic treatment in the metastatic setting
ECOG Performance status 0-1
Adequate organ function

Exclusion

Prior treatment with any KRAS inhibitor
Chronic or current active infection requiring systemic treatment within 1 week prior to the first dose of study drug
Known active CNS metastases

What this trial measures

  • Overall Survival (OS)Up to approximately 3 years

    Defined as the time from the date of randomization to the date of death due to any cause.

  • Progression-free survival (PFS) by BICRUp to approximately 2 years

    Defined as the time from the date of randomization to the date of the first documented progression as determined by blinded independent central review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause.

  • Objective Response by BICRUp to approximately 2 years

    Defined as complete response (CR) or partial response (PR) as determined by BICR per RECIST v1.1.